FDA Considering Reducing Warnings Contained In DTC Advertisements

The U.S. Food and Drug Administration is considering reducing the risks portion of direct to consumer (DTC) advertisements. In a recent request for comments, the FDA recognized that there are conflicting viewpoints at work. Some making comments, primarily pharmaceutical manufacturers, argue that the “major statement” – the currently required disclosure of a drug’s major risks – is often quite long. They say this “may result in reduced consumer comprehension, minimization of important risk information, and, potentially, therapeutic noncompliance due to fear of side effects.” But it appears that each of the above objections to the current standard on an individual basis, that shows is minimal. Let’s take a look at each:

Reduced consumer comprehension: This issue is, hopefully, addressed when consumers talk with their doctors about the potential use of a prescription drug. After all, the DTC commercials at issue are for drugs that must be prescribed by a physician and therefore require a conversation with a doctor. Consequently, removing the warnings from DTC advertisements would result in more consumers asking for particular drugs – a result that pharmaceutical manufacturers would certainly like to achieve.

Minimization of important risk information: This issue is a red herring. After all, the alternative is to completely remove some risks from the advertisement and leave only the “serious and actionable” risks. That begs the question: who will decide which risks are “serious and actionable”? Is it the seriousness of the risk or the likelihood of the risk that matters? At what point does a rare but deadly risk cross that threshold? As the only players involved in the promulgation of DTC ads, the likely answer is either the manufacturer or the FDA, but the FDA’s request for comments provides no indication how these questions would be resolved.

Therapeutic noncompliance due to fear of side effects: This only applies to patients already taking the drug (a patient cannot be noncompliant regarding a medication he is not taking), so again, it seems like either the patient has spoken with his physician or has decided on his own that the side effects are not worth the risk. Removing risks from advertisements for this reason would remove the ability of consumers to make their own medical decisions.

The other side is concerned that DTC ads “do not include adequate risk information or leave out important information,” and the FDA recognized that to be true. That’s a valid concern because the FDA has minimal oversight of DTC advertisements. While the FDA does review DTC ads, its focus is on whether the drugs themselves are safe and effective. The FDA wants to be sure that the advertisements do not misbrand those drugs. The agency is not determining whether the advertisements are true, false, or deceptive. The Government Accountability Office recognized that the FDA only reviews a “small portion of the DTC materials it receives.” Interestingly, the FDA admitted this to be true. The GAO said the FDA cannot insure that it even looks at every DTC advertisement, much less assess whether those ads satisfy the current rules.

This move by the FDA could have dangerous consequences to consumers. In an area that is already under constant criticism because of the deceptive nature of DTC advertisements, it’s inconceivable that the FDA would be looking to make commercials less informative. Add the obvious and logical assumption by consumers that fewer warnings in new ads, as compared to those in the recent past, means that the drugs are safer, and the deceptive nature of DTC advertisements will increase exponentially. Consumers need to be aware of these potential changes so they can avoid being fooled into assuming that fewer advertised risks equates to safer drugs. If you need additional information on this subject, contact Rebecca Gilliland, a lawyer in our firm’s Consumer Fraud Section, at 800-898-2034 or by email at Rebecca.Gilliland@beasleyallen.com.